Bicarbonate versus hypertonic saline nebulization for improving lung function in children with cystic fibrosis: A randomized controlled trial

Cystic fibrosis is an inherited disorder characterized by dysfunction of CFTR, an anion channel present in a diverse range of epithelial tissues. Specifically in the lungs, it plays a role in airway hydration and pH regulation. CFTR dysfunction leads to defective mucociliary clearance causing thick mucus plugging and repeated infections. Although survival is gradually improving, majority patients still succumb to respiratory failure. In resource limited settings, there are only limited affordable therapies. CFTR modulators and dornase alpha are expensive and not readily available, leaving chest physiotherapy and hydrator therapies (nebulization with 3%saline) as the mainstay of treatment of CF patients in our country.

Recent studies have highlighted the potential therapeutic benefits of bicarbonate inhalation in CF. Bicarbonate, a key ion transported by CFTR, plays a crucial role in modulating airway pH and influencing mucin properties. Alkalinization of airway surface liquid with bicarbonate has shown promise in preclinical models and early clinical trials, demonstrating improved mucus rheology, enhanced drug permeation, and reduced bacterial biofilm formation. Sodium bicarbonate, is an inexpensive, readily available drug. Due to its high osmolarity, with an additional useful property of alkaline pH, it may perform better than hypertonic saline for improving lung health in CF patients in poor resource settings.

But no RCT till date has compared 3% NS nebulization with sodium bicarbonate in patients with CF with respect to clinical outcomes. The current study will explore repurposed novel utilization of an easily available drug. As CF is a lifelong disease, long-term improvement in lung health and quality of life will be multi-fold, if detected.